It is generally known that active as well as passive smoking of tobacco products, such as cigarettes, cigars and pipe tobacco presents serious health risks to the user and those subjected to secondary smoke. It is also known that the use of smokeless forms of tobacco, such as chewing tobacco, spit tobacco and snuff tobacco, presents serious health risks to the user. Furthermore, the use of tobacco products in public areas is increasingly either restricted or socially unacceptable. Consequently, smokers and other tobacco users often try to quit the potentially deadly habit. Others may be forced to cut back on the amount of tobacco used as employment and social settings increasingly restrict smoking and other tobacco use.
Although the damaging effects of tobacco usage are well known, most individuals who are nicotine dependent have great difficulty in overcoming their dependence on nicotine, typically in cigarette form. The difficulty arises in part due to the highly addictive nature of nicotine and the strong nicotine withdrawal symptoms that can occur when one begins to deprive the body of the nicotine to which it has grown dependent. Indeed, overcoming nicotine withdrawal symptoms is a critical challenge for those attempting to conquer nicotine dependence.
Nicotine withdrawal symptoms, particularly nicotine cravings, may arise in several ways. For instance, studies have shown that following a quit attempt, smokers report moderate levels of steady nicotine craving throughout the day. This craving can prove too much for some, leading to relapse and a return to tobacco usage for some of those individuals attempting to quit. In addition to steady cravings, smokers may also experience episodic, or acute, cravings. These acute cravings may be provoked by a number of stimuli, such as exposure to smoking related cues, seeing smoking paraphernalia, being in proximity to others engaged in smoking, or inhaling second hand smoke. Such episodic cravings may also lead to relapse if effective coping measures are not employed by the individual.
In an attempt to assist those who wish to eliminate or reduce tobacco usage, efforts have been made to provide those in need with some level of nicotine craving relief. Historically, these efforts have focused on the activity and administration of nicotine itself. This nicotine replacement therapy (NRT) helps to combat the intense nicotine withdrawal symptoms encountered by many individuals upon quitting smoking or other tobacco usage. In recent years, NRT has been successfully commercialized in both the United States and elsewhere. Such commercial NRT offerings include nicotine gums, and nicotine transdermal patches (e.g., NICODERM® brand patches and NICORETTE® brand gums sold by GlaxoSmithKline Consumer Healthcare).
In addition to traditional gums and patch NRT offerings, more recently, nicotine containing lozenges have been introduced commercially both within and outside the United States. For example, COMMIT®, brand lozenges offer individuals an alternative form of NRT. U.S. Pat. No. 5,110,605 to Acharya et al. relates to lozenge compositions which comprise polycarbophil and alginic acid components. Other examples of nicotine containing lozenge formulations are found in a number of publications, including but not limited to, U.S. Pat. No. 4,967,773 to Shaw; U.S. Pat. No. 5,549,906 to Santus; U.S. Pat. No. 6,183,775 to Ventouras; and WO 2007/104575 to Axelsson et al. Similarly, U.S. Pat. Nos. 5,593,684; 5,721,257 and 5,362,496 (all to Baker et al.) disclose methods and therapeutic systems for smoking cessation, utilizing both transdermal nicotine delivery for obtaining base-line nicotine plasma levels, and transmucosal administration of nicotine to satisfy transient cravings. While such means are useful as aids to reduce or quit smoking, there is an ongoing need to provide improved lozenge formulations to assist individuals in quitting nicotine usage. In particular, there remains a need to develop lozenge forms which provide the traditional levels of craving relief to an individual but are designed to improve user compliance with an NRT program. In particular, a smaller lozenge, with comparable or faster dissolution time and onset of craving relief would boost user compliance with an NRT regimen and would be advantageous.
The present invention provides nicotine lozenge formulations with improved organoleptics, improved onset of delivery and reduced dissolution time in the oral cavity and, thereby, improved user compliance.